【expected usage】

This kit is used for the in vitro qualitative detection of influenza A virus antigen, influenza B virus antigen, respiratory syncytial virus antigen and respiratory adenovirus antigen in oral throat swab samples.

This kit cannot be used to distinguish various virus subtypes and is suitable for auxiliary diagnosis of acute upper respiratory tract infections caused by the above viruses. The results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases. The clinical diagnosis and treatment of patients should be comprehensively considered based on their symptoms/signs, medical history, other laboratory tests, and treatment response.

Influenza A virus, influenza B virus, respiratory syncytial virus and respiratory adenovirus can all cause respiratory infections. The clinical symptoms are similar, mainly including fever, cough, nasal congestion, throat discomfort, fatigue, headache, muscle aches and other symptoms. Some patients Accompanied by shortness of breath, bronchitis or pneumonia.

1. Influenza A virus (IA) and influenza B virus (IB)

Influenza virus belongs to the Orthomyxoviridae family, and its genome consists of 8 segments of single-stranded negative-sense RNA. According to the differences in viral nucleoprotein (N protein) and matrix protein (M protein), they are divided into influenza A viruses, influenza B viruses and influenza C viruses. At present, the main causes of human influenza epidemics are influenza A and influenza B viruses. The outermost layer of the influenza virus particle is an envelope, which is acquired when the virus is released from the host cell. The main components come from the host cell, but the protein encoded by the viral gene is inserted into the membrane. Two of the glycoproteins have important antigenicity, namely hemagglutinin (HA) and neuraminidase (NA). Based on the differences in antigenicity of HA and NA proteins, influenza A viruses can currently be divided into 18 H subtypes (H1~H18) and 11 N subtypes (N1~N11). Under the viral envelope is a membrane-bound matrix protein (M protein), and the innermost layer is a core composed of nucleic acid and nucleoprotein (N protein). Influenza viruses can infect and replicate in all types of cells in the respiratory tract. The main mechanism of disease is cell damage and death caused by viral replication. Influenza A virus or influenza B virus is mainly spread through air droplets. The main clinical symptoms of infected patients are local respiratory symptoms such as coughing, sneezing, runny nose, nasal congestion, and throat discomfort, as well as fever, fatigue, headache, muscle aches, etc. Systemic symptoms, some patients are accompanied by shortness of breath, bronchitis or pneumonia, which can last for weeks or months.

2. Adenovirus (ADV)

Human adenovirus belongs to the Adenoviridae family and has a linear double-stranded DNA genome. Virus particles are composed of a protein shell and a nucleoprotein core (including DNA genome and attached proteins). They are non-enveloped and have a diameter of 65 to 80 nm. So far, at least 51 different serotypes of adenovirus have been found to cause disease in humans. The vast majority of primary infections occur in children under 5 years old and are generally self-limiting, but they can cause severe disseminated infections in neonates and immunocompromised patients. Adenovirus is mainly spread through droplets, and virus-containing aerosols and dander are highly contagious. In addition, it is also transmitted through the fecal-oral route.

3. Respiratory syncytial virus (RSV)

RSV is a single-stranded negative-sense RNA virus and one of the main pathogens causing acute respiratory infections in infants and young children. The natural immunity generated after infection is incomplete, and repeated infections are common in all age groups. RSV often causes flu-like symptoms in adults. Compared with influenza, the clinical manifestations of RSV infection include more obvious nasal congestion, sinus infection and sputum production, which lasts an average of 9.5 days, which is longer than the 6.8 days of influenza. RSV can cause serious infections in the elderly and immunocompromised patients. In addition, RSV infection is also common in transplant and cancer patients. RSV is highly contagious and is spread from person to person through contact with respiratory secretions. The virus remains active on respiratory secretions for up to 8 hours on a table, 1.5 hours on latex gloves, and at least 30 minutes on paper and skin. RSV enters the body and proliferates in the throat, causing symptoms such as fever, cough, nasal congestion, pharyngitis, and otitis media. When it spreads to the lower respiratory tract, the virus continues to proliferate, leading to necrosis of alveolar epithelial cells, and the patient suffers from hypoxia, shortness of breath, wheezing, etc. Symptoms may even cause difficulty breathing in severe cases.

Clinical or laboratory diagnostic methods include virus isolation and culture, enzyme-linked immunoassay, PCR, immunofluorescence, etc.

The kit consists of test card and sample processing solution.

Among them, the test cards of different types of kits are coated with corresponding influenza A virus/influenza B virus/respiratory syncytial virus/respiratory adenovirus monoclonal antibodies and anti-mouse IgG polyclonal antibodies.

Among them, the sample processing solution specifications are divided into two types: large packaging and single-serve packaging. The large package contains: sample processing solution in a dropper bottle, extraction bottle and matching dripper. The single-serve package contains: sample processing solution in a stick and matching dripper.